266/2009 Sb.
GOVERNMENT REGULATION
of 27 June. July 2009
on technical requirements for marine equipment
Change: 101/2010 Sb.
Change: 228/2006.
Change: 335/2009 Sb.
Government orders under section 22 of Act No. 22/1997 Coll., on technical
requirements for products and amending and supplementing certain acts, as amended by
Act No. 207/2002 Coll. (hereinafter the "Act") to implement section 11 para. 2, §
11A. 2, section 12 and 13 of the Act:
§ 1
(1) this regulation incorporates the relevant provisions of the European Union ^ 1) and
laying down technical requirements for equipment intended for use on board
sea-going vessels ^ 2), which are listed in annex 1 to this
Regulation (hereinafter referred to as "marine equipment"). Marine equipment are
established products within the meaning of § 12 para. 1 (b). and) of the Act.
(2) this Regulation shall not apply to marine equipment intended for use on
Board the warships.
§ 2
In this regulation, the radiocommunications equipment means equipment referred to
in chapter IV. The International Convention for the safety of life at sea
1974 ^ 3) (hereinafter referred to as "SOLAS") and two-way radiotelephone
appliance VHF survival craft.
§ 3
(1) marine equipment shall meet the requirements set out in annex 1 to the
application of this regulation.
(2) compliance with the requirements referred to in paragraph 1 shall be determined in accordance with procedures
testing standards and conformity assessment procedures set out in annex 1 to the
application of this regulation.
(3) the contents of the various conformity assessment procedures is given in annex No.
2 to this regulation.
(4) the requirements of other legislation on marine equipment, for the purposes
the conformity assessment shall not be used.
§ 4
(1) For the assessment of conformity of marine equipment authorization may be granted
pursuant to section 11 of the Act to the legal entity that meets the requirements set out in annex
# 3, to this regulation.
(2) Office for standards, metrology and testing
at least once every two years, runs in accordance with § 11 para. 4 control activities
the notified body, if it meets the criteria referred to in annex 3 to this
of the regulation.
(3) if part A of annex 2 to this regulation allows to execute
a specific part of a conformity assessment procedure through another person, must
This person meet the same requirements as notified body.
§ 5
(1) marine equipment, which is intended to be placed on board a sea
the vessel, or that is placed on board, must be provided with
mark of conformity, unless otherwise provided in this regulation.
(2) the manufacturer or his authorised representative shall affix the mark of conformity
marine equipment, which meets the requirements referred to in annex 1 to the
of this regulation and whose compliance was verified by the relevant
conformity assessment. Mark of conformity with the marine equipment provides at the end of
the production phase.
(3) for the mark of conformity shall be notified body, the manufacturer or his
authorized representative identification number of the notified body which
carried out the conformity assessment procedure, if it is involved in the control phase
production, and the last two digits of the year in which the maritime
the conformity mark is affixed.
(4) marine equipment or to its data plate must bear the
matches always in a visible, legible and indelible manner, and that all the
the lifetime of the device. If this is not technically possible, glue
mark of conformity to the product packaging or the leaflet.
(5) the marine equipment, its a descriptive label, package or leaflet must not be
bear the inscription, or which can be confused with the brand
of conformity.
(6) the graphical representation of the mark of conformity is given in annex 4 to this
of the regulation.
§ 6
(1) if it is found that the marine equipment bearing the mark
compliance, may endanger the safety and health of persons, property or the sea
environment, even if they are properly installed, maintained and used in the
accordance with its intended purpose, such a facility may be saved
protective measures under other legislation ^ 4).
(2) in the case that was for naval equipment saved a safeguard measure
in accordance with paragraph 1, it shall be indicated in the notification of the decision on the imposition of safeguard
measures pursuant to § 7 (2). 8 of the Act, whether the non-compliance was caused by
and the failure to satisfy the requirements laid down in) Annex 1 to this regulation,
b) incorrect application of the testing standards referred to in § 3 (1). 2, or
c) shortcomings in the testing standards referred to in § 3 (1). 2.
§ 7
(1) it is necessary to replace the marine equipment on board a seagoing
the vessel, which is located in the port of a State which is not a Member State
The European Union, and if, due to exceptional circumstances it is not possible
place on board the naval facility, which is equipped with a mark of conformity,
You can put the other on board marine equipment, provided that the
and) for maritime equipment is attached documentation issued by the entity,
that is equivalent to the certification, based on the international
the contracts concluded between the European Union and by that State, or
(b)) for maritime equipment is attached documentation certifying the compliance with
the requirements of the International Maritime Organisation (the "IMO") issued by the
a State which is a Contracting Party to international conventions setting out the
the requirements for this device, if the contract is concluded under subparagraph (a))
or if there is no equivalent body in that State.
(2) exceptional circumstances consist in particular of excessive long time
or unreasonably high costs associated with the acquisition of naval
a device provided with a mark of conformity.
(3) the master of a sea-going vessel on board which was located the maritime
the device referred to in paragraph 1, without undue delay, provide the information
listed in the documentation for the device the maritime authority. Without undue delay
After a seagoing vessel arrives at the port in the territory of the European Union,
must be marine equipment referred to in paragraph 1 is replaced by the maritime equipment
provided with a mark of conformity.
(4) If a maritime radio communications device, the device may not cause
adversely on the radio-frequency spectrum.
§ 8
On marine equipment, which had been placed on board a sea-going vessel
before the date of entry into force of this regulation, are not subject to the provisions of
of this regulation.
§ 9
This Regulation shall enter into force on the fifteenth day following the date of its publication.
Prime Minister:
in of PhDr. Cock in r.
Deputy Prime Minister and Minister for Foreign Affairs
Minister of transport:
Ing. Slamečka, MBA in r.
Annex 1
Marine equipment, technical requirements for marine equipment, test
procedures and the conformity assessment procedures to demonstrate compliance with these requirements
1. Marine equipment listed in column 2 of annex a. 1 of Council directive
96/98/EC of 20 May 1999. December 1996 on marine equipment, as amended by
amended, the European Union (hereinafter referred to as "the Directive 96/98/EC").
2. Marine equipment must comply with the technical provisions set out in the
columns 3 and 4 of the annex and of Directive 96/98/EC.
3. Compliance with the requirements referred to in point 2 shall be determined according to the test procedures
standards and conformity assessment procedures set out in columns 5 and 6 of the annex
And Directive 96/98/EC.
4. the provisions amending the annex 1 of Directive 96/98/EC,
apply from the date on which the Member States of the European Union deadline for the
adoption and publication of the provisions necessary to comply with
the EU regulation, which amends this directive. '.
Annex 2
The modules for the conformity assessment and technical documentation
A. conformity assessment modules
1.
EC TYPE-EXAMINATION (MODULE B)
1. the notified body must ascertain and confirm that the sample
representative of the production envisaged, meets the provisions of this
regulation related to this production.
2. the manufacturer or his authorised representative shall obtain from the person
He had chosen, application for EC type-examination. The application must include
— the name and address of the manufacturer and, if the application is lodged by the authorised representative,
his name and address,
-a written declaration that the same application has not been lodged simultaneously with other
the notified body,
— the technical documentation described in point 3.
The applicant shall give the notified body a specimen, representative of
estimated production (hereinafter referred to as "type"). A type may cover several
versions of the product provided that the differences between the versions
do not affect the level of safety and the other requirements concerning the functional
the eligibility of a product. Notified body may request further samples,
If the test programme so requires.
3. the technical documentation must enable the conformity of the product with the
requirements of the relevant provisions of this regulation. The technical documentation
It must, as far as relevant for such assessment, cover the design, construction
building standard, manufacture, installation and operation of the product in accordance with the description
the technical documentation referred to in part B of this annex.
4. the notified body
a) examine the technical documentation and verify that the type has been manufactured in the
conformity with the technical documentation,
b) perform or have performed the appropriate examinations and necessary tests to
determine whether the requirements of this regulation have been met,
(c)) agree with the applicant the location where the examinations and necessary tests
performed.
5. Where the type meets the relevant provisions of this regulation, shall
notified body to issue the EC type-examination certificate to the applicant.
The certificate must contain the name and address of the manufacturer, the details of the
device, conclusions of the examination, conditions for its validity and the data
necessary to identify the approved type. The certificate must be
accompanied by a list of the relevant parts of the technical documentation, and a copy
shall keep the notified body. If the notified body refuses to issue the
EC type-examination certificate to the manufacturer, this fact in detail
reasons for such denial. If a manufacturer reapplies for type-approval of devices,
which has not been issued with the certificate type, you must obtain from the Administration
include all relevant documentation to the person, including the original reports on the
the tests, a detailed statement of the previous refusal and details
all modifications made to the device.
6. The applicant must inform the person that the certification is available
technical documentation concerning the EC type-examination certificate,
all modifications to the approved product which must receive additional
approval where such changes may affect the conformity with the essential
requirements or with the prescribed conditions for use. This
the additional approval shall be given in the form of the Certificate Supplement to the initial EC
type-examination.
7. on request, each notified State authorities of States
the flag of the European Union and other notified parties provide
relevant information concerning the EC type-examination certificate and
additions issued and withdrawn.
8. the other notified the person may receive copies of the EC certificates
type-examination and their additions. The annexes to the certificates must be
kept available to the other notified parties.
9. the manufacturer or his authorised representative must keep with the technical
documentation copies of EC type-examination certificates and their
additions for a period ending at least 10 years from the date of manufacture of the product.
2.
CONFORMITY TO TYPE (MODULE C)
1. the manufacturer or his authorised representative ensures and declares that the
the products concerned are in conformity with the type as described in the EC
type-examination certificate and satisfy the requirements of the provisions of this regulation, which
apply to it. The manufacturer or his authorised representative shall affix each
mark of conformity the product and draw up a written declaration of conformity.
2. The manufacturer shall take all measures necessary in order that the manufacturing process
ensures compliance of the manufactured products with the type as described in the EC
type-examination and with the requirements of the provisions of this regulation, that the
them.
3. the manufacturer or his authorized representative must keep a copy of the Declaration of
conformity for at least 10 years from the date of manufacture of the product.
3.
PRODUCTION QUALITY ASSURANCE (MODULE D)
1. a manufacturer who satisfies the obligations of point 2 ensures and declares
that the products concerned are in conformity with the type as described in the EC
type-examination. The manufacturer or his authorised representative shall affix each
mark of conformity the product and draw up a written declaration of conformity. Brand
matches must be accompanied by the identification number of the notified body
responsible for the surveillance as specified in point 4.
2. the manufacturer must operate an approved quality system for production, final product
product inspection and testing as specified in point 3 and shall be subject to surveillance as specified in point 4.
3. Quality System
3.1. the manufacturer must lodge with the notified body, that his choice, the request for
assessment of the quality system for the products concerned. The application must include
and) all relevant information for the product category envisaged,
(b)) the quality system documentation,
(c) the technical documentation of the approved type) and a copy of the certificate of EC
type-examination.
3.2. The quality system must ensure compliance of the products with the type as described in the
EC type-examination certificate. All the elements, requirements and provisions
used by the manufacturer must be documented in a systematic and orderly
form of written measures, procedures and instructions. This documentation system
quality must permit a consistent interpretation of the quality programmes, plans,
quality manuals and quality records. System documentation
It must contain in particular an adequate description of the
a) the quality objectives and the organisational structure, responsibilities and powers
management with regard to product quality,
(b)) of the production process, quality control and quality assurance techniques and
systematic actions that will be used,
c) the examinations and tests that will be carried out before, during
and after manufacture, the frequency with which,
d) quality records, such as inspection reports and results
and test data, calibration data, reports concerning the qualifications of the personnel concerned,
e) means to monitor the achievement of the required quality
products and the efficient operation of the quality system.
3.3. the notified body shall assess the quality system to determine whether the
satisfies the requirements referred to in 3.2. For systems which comply with the relevant
harmonized standard, compliance with these requirements. In the team
Auditors must be at least one member with experience of assessing the
the product technology concerned. The assessment procedure must include an assessment
inspection on the manufacturer's premises. The decision must be notified to the
producers. The notification must contain the conclusions of the examination and the reasoned decision of the
about the assessment.
3.4. the manufacturer shall undertake to fulfil the obligations arising from the
quality system as approved and to maintain it in order to permanently
adequate and efficient. The manufacturer or his authorised representative shall inform the
by a person who has approved the quality system of any intended
updating of the quality system. Notified body shall evaluate the proposed
the changes and decide whether the modified quality system will still satisfy the
requirements referred to in point 3.2 or whether a re-assessment is required.
Notified body shall notify the manufacturer of its decision. The notification must
contain the conclusions of the examination and the reasoned assessment decision.
4. Surveillance under the responsibility of the notified body
4.1. the purpose of surveillance is to ensure that the manufacturer duly fulfils the obligations
arising out of the approved quality system.
4
2. The manufacturer shall obtain from the person in order to control access to the
the places of manufacture, inspection, testing and storage, and
provide it with all necessary information, in particular
and) the quality system documentation,
(b)) the quality records, such as inspection reports and results
and test data, calibration data, qualification reports of the relevant
workers.
4.3. the notified body shall periodically carry out audits to make sure that
manufacturer maintains and applies the quality system and to transmit a report on manufacturers
audit.
4.4. Additionally, the notified body the manufacturer
unexpected visits. When such visits
can the notified body, if necessary, carry out or have carried out
tests to verify that the quality system is functioning correctly. Notified body
the person shall provide the manufacturer with a visit report and, if a test
a test report.
5. The manufacturer must, for a period of at least 10 years from the date of manufacture of the product
and) the documentation referred to in 3.1. in subparagraph (b)),
(b)) the updating referred to in second sentence of point 3.4,
(c)), the decisions and reports of the notified body referred to in point 3.4 of the sentence
the fourth and fifth and in points 4.3 and 4.4.
6. each notified body shall, on the request of the public authorities of the States
the flag of the European Union and other notified appropriate persons
for information about system approvals issued and withdrawn.
4.
PRODUCT QUALITY ASSURANCE (MODULE E)
1. a manufacturer who satisfies the obligations of point 2 ensures and declares
that the products concerned are in conformity with the type as described in the EC
type-examination. The manufacturer or his authorised representative shall affix each
mark of conformity the product and draw up a written declaration of conformity. Brand
matches must be accompanied by the identification number of the notified body
responsible for the surveillance as specified in point 4.
2. the manufacturer must operate an approved quality system for final inspection and
testing as specified in point 3 and shall be subject to surveillance as specified in point 4.
3. Quality System
3.1. the manufacturer must lodge with the notified body, that his choice, the request for
assessment of the quality system for the products concerned. The application must include
and) all relevant information for the product category envisaged,
(b)) the quality system documentation,
(c)), where appropriate, the technical documentation the approved type and a copy of the
EC type-examination certificate.
3.2. Each product under the quality system must be checked and must
be made to the appropriate tests in order to ensure compliance with the relevant
the requirements of the provisions of this regulation. All the elements, requirements, and
provisions adopted by the manufacturer must be systematic and orderly
documented in the form of written measures, procedures and instructions. This
the quality system documentation must permit a consistent interpretation of the programs
quality, quality plans, quality manuals and quality records.
The quality system documentation shall contain in particular an adequate description of the
a) the quality objectives and the organisational structure, responsibilities and powers
of the management with regard to product quality,
(b)) the examinations and tests that will be carried out after manufacture,
(c)) the means of supervision of the effective operation of the system
the quality,
d) quality records, such as inspection reports and results
and test data, calibration data, qualification reports of the staff concerned.
3.3. the notified body shall assess the quality system to determine whether the
satisfies the requirements referred to in 3.2. For systems which comply with the relevant
harmonized standard, compliance with these requirements. In the team
Auditors must be at least one member with experience of assessing the
the product technology concerned. The assessment procedure must include an assessment
inspection on the manufacturer's premises. The decision must be notified to the
producers. The notification must contain the conclusions of the examination and the reasoned decision of the
about the assessment.
3.4. the manufacturer shall undertake to fulfil the obligations arising from the
quality system as approved and to maintain it in order to permanently
adequate and efficient. The manufacturer or his authorised representative shall inform the
by a person who has approved the quality system of any intended
updating of the quality system. Notified body shall evaluate the proposed
the changes and decide whether the modified quality system will still satisfy the requirements
referred to in point 3.2 or whether a re-assessment is required. Notified body
shall notify the manufacturer of its decision. The notification must contain the conclusions of the examination and
the reasoned assessment decision.
4. Surveillance under the responsibility of notified body
4.1. the purpose of surveillance is to ensure that the manufacturer duly fulfils the obligations
arising out of the approved quality system.
4.2. the manufacturer shall allow the notified person for inspection purposes to the
the space intended for the inspection, testing and storage and provide it with
all necessary information, in particular
and) the quality system documentation,
(b)) the technical documentation,
c) quality records, such as inspection reports and results
and test data, calibration data, qualification reports of the relevant
workers.
4.3. the notified body shall periodically carry out audits to make sure that
manufacturer maintains and applies the quality system and shall provide a report on the
audit.
4.4. Additionally, the notified body the manufacturer
unexpected visits. When such visits
can the notified body, if necessary, carry out or have carried out
tests to verify that the quality system is functioning correctly. Notified body
the person shall provide the manufacturer with a visit report and, if a test
a test report.
5. The manufacturer must, for a period of at least 10 years from the date of manufacture of the product
and) the documentation referred to in point 3.1 (b)),
(b)) the updating referred to in second sentence of point 3.4,
(c)) the decisions and reports of the notified body referred to in the fourth and fifth sentence
point 3.4, point 4.3 and point 4.4.
6. each notified body shall provide, upon request, to government authorities of the State
the flag of the European Union and other notified appropriate persons
information concerning the quality system approvals and withdrawn.
5.
PRODUCT VERIFICATION (MODULE F)
1. the manufacturer or his authorised representative ensures and declares that the
the products referred to in point 3 are in conformity with the type described in the EC
type-examination.
2. The manufacturer shall take all measures necessary in order that the manufacturing process
ensures compliance of the výrodků with the type described in the EC type-examination certificate
type. The manufacturer must affix the mark to each product and draw up a written
the Declaration of conformity.
3. the notified body carry out the appropriate examinations and tests in order to
Verify the conformity of the product with the requirements of the provisions of this regulation, and either
by examination and testing of every product as specified in point 4 or by examination and
testing of products on a statistical basis as specified in point 5.
3.1. The manufacturer or his authorized representative shall keep a copy of the statement
of conformity for at least 10 years from the date of manufacture of the product.
4. Verification by examination and testing of every product
4.1. All products must be individually examined and must be
appropriate tests in order to verify their conformity with the type
as described in the EC type-examination certificate.
4.2. the notified body must affix to each approved product or
Let raise its identification symbol and draw up a written
a certificate of conformity concerning the tests carried out.
4.3. the manufacturer or his authorized representative must be able to
request certificates of conformity certification.
5. Statistical verification
5.1. the manufacturer must present his products in the form of stejnodobých benefits and take
all measures necessary in order that the manufacturing process ensures the uniformity of
each batch produced.
5.2. the verification shall be available for all products in the form of
homogeneous lots. From each batch of the random sample.
Products in a sample shall be individually examined and appropriate
tests in order to check the conformity of the products with the requirements of the provisions of the
This regulation, which applies to them, and to determine whether the lot is
accepted or rejected.
5.3. in the case of accepted lots, the notified body shall affix, or
cause to be affixed, its identification number to each product and draw up a written
certificate of conformity relating to the tests carried out. All products
from the sample may be placed on the market except for those products from the sample
which were found not to match.
If a lot is rejected, the notified body shall take appropriate measures,
to prevent the placing on the market of that lot. In the event of frequent rejection
notified body doses may suspend the statistical verification.
During the production process the manufacturer may affix the responsibility of the
the identification number of the notified body.
5.4. the manufacturer or his authorized representative must be able to
request certificates of conformity certification.
6.
UNIT VERIFICATION (MODULE G)
1. The manufacturer ensures and declares that the product concerned, which has been issued
the certificate referred to in point 2, conforms to the requirements of this regulation, that the
it. The manufacturer or his authorised representative must affix the
mark of conformity and draw up a declaration of conformity.
2. the notified body checks for each individual product and carry out
appropriate tests to ensure its conformity with the provisions of this
of the regulation. Notified body shall affix, or cause to be on the approved product
its identification number and shall issue a certificate of conformity relating to the
the tests carried out.
3. the aim of the technical documentation is to enable conformity with the requirements of
the provisions of this regulation and an understanding of the design, manufacture and
operation of the product.
7.
FULL QUALITY ASSURANCE (MODULE H)
1. a manufacturer who satisfies the obligations of point 2 ensures and declares
that the products concerned satisfy the requirements of the provisions of this regulation which is
to them. The manufacturer or his authorised representative must affix the
mark of conformity and draw up a written declaration of conformity. Conformity mark shall
be accompanied by the identification number of the notified body responsible for the
surveillance as specified in point 4.
2. the manufacturer must operate an approved quality system for design, production, final product
product inspection and testing as specified in point 3 and shall be subject to surveillance as specified in point 4.
3. Quality System
3.1. the manufacturer shall submit for the products concerned by the notified body an application for
assessment of the quality system. The application must include
and) all relevant information for the product category envisaged,
(b) the quality of the documentation).
3.2. The quality system must ensure compliance of the products with the requirements of
the provisions of this regulation that apply to them. All the elements,
requirements and provisions adopted by the manufacturer must be systematically and
orderly manner in the form of written measures, procedures and instructions.
This quality system documentation must permit a consistent interpretation
the quality and procedures such as quality programmes, plans, manuals
quality and quality records. Must contain in particular an adequate description of the
and) the quality objectives and the organisational structure, responsibilities and powers
of the management with regard to design and product quality,
(b)) the technical design specifications, including standards, that will be used, and
in the case where the standards referred to in section 5 are not used fully, the means
that will be used to ensure that the essential requirements of the
This regulation which apply to the products,
c) inspection and design verification techniques, processes and systematic
actions that will be used when designing the products pertaining to the
the product category covered,
(d)) of the respective techniques, processes and systematic actions that will be
used in the manufacture, quality control and quality assurance techniques,
(e)) the examinations and tests that will be carried out before, during
and after production, with an indication of the frequency,
f) quality records, such as inspection reports and results
and test data, calibration data, reports concerning the qualifications of the personnel concerned,
g) means to monitor the achievement of the required quality
designs and products and the efficient operation of the quality system.
3.3. the notified body shall assess the quality system to determine whether the
satisfies the requirements referred to in 3.2. For systems that implement the relevant
harmonized standard, compliance with these requirements. In the team
Auditors must be at least one member with experience of assessing the
the product technology concerned. The assessment procedure must include an assessment
inspection on the manufacturer's premises. The decision must be notified to the
producers. The notification must contain the conclusions of the examination and the reasoned decision of the
about the assessment.
3.4. the manufacturer shall undertake to fulfil the obligations arising from the
quality system as approved and to maintain it in order to permanently
adequate and efficient. The manufacturer or his authorised representative shall inform the
by a person who has approved the quality system of any intended
updating of the quality system. Notified body shall evaluate the proposed
the changes and decide whether the modified quality system will still satisfy the
requirements referred to in point 3.2 or whether a re-assessment is required.
Notified body shall notify the manufacturer of its decision. The notification must
contain the conclusions of the examination and the reasoned assessment decision.
4. Ec surveillance under the responsibility of notified body
4.1. the purpose of surveillance is to ensure that the manufacturer duly fulfils the obligations
arising out of the approved quality system.
4.2. the manufacturer shall allow the notified person for inspection purposes to the
the places of design, manufacture, inspection, testing and
storage and must provide it with all necessary information, in particular
and) the quality system documentation,
(b)) quality records required in part of the quality system relating to
the proposal, such as results of analyses, calculations, tests,
(c)) the quality records provided for in part of the quality system relating to
manufacture, such as inspection reports and test data, about
calibration data, qualification reports of the personnel concerned.
4.3. the notified body shall periodically carry out audits to make sure that
manufacturer maintains and applies the quality system and shall provide a report on the
audit.
4.4. Additionally, the notified body the manufacturer
unexpected visits. When such visits
can the notified body, if necessary, carry out or have carried out
tests to verify that the quality system is functioning correctly. Notified body
the person shall provide the manufacturer with a visit report and, if a test
a test report.
5. The manufacturer must, for a period of at least 10 years from the date of manufacture of the product
and) the documentation referred to in point 3.1 the second sentence of subparagraph (a). (b)),
(b)) the updating referred to in second sentence of point 3.4,
(c)), the decisions and reports of the notified body referred to in point 3.4 of the sentence
the fourth and fifth and in points 4.3 and 4.4.
6. each notified body shall give the other notified parties
the relevant information concerning system approvals issued and withdrawn
the quality.
7. Design examination
7.1. the manufacturer shall lodge an application for examination of the design with a single notified
of the person.
7.2. the application shall enable understanding of the design, manufacture and operation of the product
and the assessment of conformity with the requirements of this regulation. The application must include
and) the technical design specifications, including standards, that will be used,
(b)) the necessary supporting evidence for their adequacy, in particular where
standards referred to in section 5 have not been applied in full. This supporting evidence must
include the results of tests carried out by the appropriate laboratory of the manufacturer
or on behalf of
.
7.3. the notified body shall examine the application and where the design meets the
the provisions of this regulation, which is applicable to it, shall issue to the applicant
EC design examination certificate. The certificate must contain the conclusions of the
of the examination, conditions for its validity, the necessary data for
the identification of the approved design and, where appropriate, a description of the operation of the product.
7.4. The applicant must inform by the person who issued the certificate, the EC
examination of the design of all modifications to the approved design. Changes to the approved
the proposal must be approved by the person who issued the
EC design-examination certificate where they may affect conformity with the
the essential requirements of this regulation or the prescribed conditions for
use of the product. This additional approval in the form of a supplement to the
the original EC design-examination certificate.
7.5. The notified body shall communicate to the other notified the persons concerned
information relating to the
and) EC design-examination certificates and additions issued,
(b)) the EC design-examination certificates it has withdrawn, and amendments thereto.
(B). the technical documentation the manufacturer shall grant the notified person
1. this part of the annex shall apply to all modules.
2. the technical documentation referred to in part A of this annex must include the
all relevant information and the means used by the manufacturer to ensure
the conformity of equipment with the essential requirements which apply to it.
3. the technical documentation shall enable understanding of the design,
manufacture and operation of the product, and shall enable conformity with the requirements of the
the provisions of this regulation.
4. to the extent necessary, the documentation must contain in particular an assessment
and a general description of the type)
(b)) a conceptual design, design standards, manufacturing drawings and diagrams
of components, sub-assemblies, circuits,
c) descriptions and explanations of the drawings and diagrams that are necessary for the
understanding, including product features,
d) results of design calculations carried out independent tests
e) impartial test reports,
f) tutorials for installation, use and maintenance.
5. the dossier of the proposal contains, where appropriate,
and) attestations relating to the equipment incorporated in the appliance,
b) attests and certificates relating to the methods of manufacture and/or inspection
or tracking device,
(c) all other documents allowing) the notified person improve
the assessment.
Annex 3
The requirements for authorization of persons
1. The notified body must carry out the requirements of the relevant standards of the series EN
45 000.
2. The notified body must have its registered office or place of business in the territory of
Of the European Union.
3. A notified body must be independent of all persons directly or
indirectly involved in the development, production, distribution, sales,
installation and maintenance of marine facilities.
4. A notified body, the members of their governing bodies and employees
responsible for conformity assessment shall not participate in any activities that
could endanger the independence of decision-making and objectivity in the assessment of the
of conformity.
5. The notified body must have
a) sufficient number of workers with technical knowledge and
relevant experience in the implementation of the conformity assessment
(b)) the necessary equipment,
in order to enable it to perform properly the activities of bonded with conformity assessment of marine
equipment and ensure a high level of quality.
Annex 4
A graphical representation of the conformity
Mark of conformity must have this form:
If the symbol is reduced or enlarged, must be maintained for the mutual
According to the graduation ratios in the above diagram. Different parts of the brand
must have substantially the same vertical dimension, which may not be less than
5 mm.
For small devices do not need to take into account the minimum size.
Selected provisions of the novel
Article. (II) Government Regulation No. 228/2006.
Transitional provisions
1. on the marine equipment, which was made before the date of entry into force of
This regulation, which, according to the existing legislation, the latter
mark of conformity, are not subject to the provisions of this regulation.
2. Marine equipment, which was made before the date of entry into force of
of this regulation and whose technical requirements not addressed in the regulation
Government No 266/2009 Coll., in the version in force until the date of entry into force of this
Regulation can be placed on the market and put on board a sea-going vessel
not later than 2 years from the date of entry into force of this regulation.
1) Council Directive 96/98/EC of 20 May 1999. December 1996 on marine equipment.
Commission Directive 98/85/EC of 11. November 1998, amending Directive
Of the Council 96/98/EC on marine equipment.
Commission Directive 2002/75/EC of 2 October 1998. September 2002, amending Council directive
Of the Council 96/98/EC on marine equipment.
Directive of the European Parliament and of the Council 2002/84/EC of 5 July 2004. November
2002 amending the directives on maritime safety and prevention
of pollution from ships.
Commission Directive 2008/67/EC of 30 March 2004. June 2008 amending
Council Directive 96/98/EC on marine equipment.
Commission directive 2009/26/EC of 6 May 1999. April 2009 amending
Council Directive 96/98/EC on marine equipment.
Commission directive 2010/68/EC of 22 December 2004. October 2010, amending
Council Directive 96/98/EC on marine equipment.
Commission directive 2011/75/EU of 2. September 2011, amending Directive
Of the Council 96/98/EC on marine equipment.
2) § 2 (2). 2 Act No 61/2000 Coll., on maritime navigation.
3) the negotiation of the Convention, notified under no 52/1995 Sb.
4) section 7A(1). 1 (b). a) and b) of Act No. 64/1986 Coll., on Czech trade
inspection, as amended by Act No. 22/1997 Coll., Act No. 204/2002 Coll. and the
Act No. 228/2003 Coll.
